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Clinical Development Statistician

2 weeks ago

Copenhagen, Copenhagen, Denmark IQVIA Argentina Full time

At IQVIA, we are seeking a highly skilled Clinical Development Statistician to lead components of statistical contribution to our clinical development program. This is an exciting opportunity for a statistician who wants to make a significant impact in the life sciences and healthcare industries.

The Clinical Development Statistician will implement the statistical strategies for clinical trials and regulatory submissions within the program and be accountable for the statistical deliverables. Key responsibilities include:

  • Input to statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions.
  • Lead components and fully support Biostatistics conduct in study design, protocol development, data collection, data analysis, reporting, and submission preparation.
  • Author the initial statistical analysis plan for clinical trials and regulatory submissions. Be accountable for timely completion and quality of the statistical analysis plan.
  • Support Biostatistics interactions with regulatory authorities (e.g., FDA, EMA, PMDA).
  • Be responsible for interpreting analysis results and ensuring reporting accuracy.
  • Manage outsourcing operations or work with internal statistical programmers within the responsible projects. Ensure timeliness and quality of deliverables by CRO/FSP. Conduct reviews of deliverables to ensure quality.
  • Be accountable for the TFL/CDISC package for study report and regulatory submission.